K243086 is an FDA 510(k) clearance for the Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 20, 2025, 143 days after receiving the submission on September 30, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K243086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | February 20, 2025 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |